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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, oxygen, cutaneous, for infant not under gas anesthesia
510(k) Number K860124
Device Name HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
Applicant
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Applicant Contact RONALD WIDMAN
Correspondent
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Correspondent Contact RONALD WIDMAN
Regulation Number868.2500
Classification Product Code
KLK  
Date Received01/14/1986
Decision Date 05/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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